# K100822: Xpert Mrsa/SA Nasal Assay

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Jun 1, 2010 after 70 days
- Product code: NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K243070: Xpert® SA Nasal Complete (2024), 0 descendants of its own

## Recalls of this device
- Aug 6, 2025 · Class II · Z-0414-2026: As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

Source page: https://510kreport.com/device/K100822
Methodology: https://510kreport.com/methodology